There is a huge amount of work required to put together a robust regulatory submission. If studies are left to the last minute, there is a risk that the results from those studies could trigger higher tier concerns that will take longer than anticipated to resolve.

Talk to your regulator

They’re there to help and most of the time they’ll be happy to provide advice on regulatory issues. If you open the lines of communication they’re more likely to get in touch with questions when evaluating your dossier which could help lead to a positive outcome.

Be open and honest

Be open and honest with your regulator. It isn’t worth trying to hide obvious deficiencies in your submissions – they’ll find them.

It’s worth explaining everything in detail, even if it seems obvious to you. This clarity will prevent anything from being overlooked and help your case.

Explain clearly

For biocides and general chemicals the product's end use needs to be clearly explained. This will determine what studies are required and the way the risk assessment is carried out to ensure a robust risk assessment.

Sort out the GAP early

For agrochemicals one of the key cornerstones of any submission is the GAP. This forms the basis for risk assessments and changes at any stage during dossier preparation could mean the need for further studies.

When you talk to JSC you deal with specialists from both regulatory and commercial backgrounds. You can draw upon expertise that extends across agrochemicals, biocides and general chemicals, as well as an extensive network of contacts in the EU Commission and Member State regulatory authorities.

JSC have been providing regulatory advice for over 20 years, so we know the importance of specialists. That’s why we’ve put together a team of people who know the regulation landscape like no-one else.